Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q10: Pharmaceutical Quality System

Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q10: Pharmaceutical Quality System Q10: Pharmaceutical Quality System. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA. 2023-11-02 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyinternational-conference on harmonisationICHICH of technical-requirementsregistration of pharmaceuticalspharmaceuticals for human-useICH guidanceQ10pharmaceutical quality system Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q10: Pharmaceutical Quality SystemHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/quality/adoption-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-guidance-pharmaceutical-quality-system.html Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q10: Pharmaceutical Quality SystemHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/qualite/adoption-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ligne-directrice-systeme-qualite.html

Q10: Pharmaceutical Quality System. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

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